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Selective Lobar Blockade and Bronchial Blockers

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ClinicalTrials.gov Identifier: NCT02032342
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Dammam University

Brief Summary:
Selective lobar blockade (SLB) is a specific technique that allows collapse of the operated lobe during thoracic surgery while the other lobes are ventilated. It is associated with the improvement of arterial oxygenation during one lung ventilation (OLV) for thoracic with providing adequate surgical access. The purpose of this study is to compare the efficacy of three bronchial blockers, namely an Arndt® wire-guided endobronchial blocker, a Cohen Flexi-tip endobronchial blocker or a Fuji Uni-blocker, for achieving selective lobar collapse.

Condition or disease Intervention/treatment Phase
Elective Thoracic Surgery One Lung Ventilation Device: Endobronchial double lumen tube Device: Arndt® blocker Device: Cohen blocker Device: Fuji Uni-blocker Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selective Lobar Blockade: A Randomized Trial of Three Bronchial Blockers
Actual Study Start Date : January 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Active Comparator: Fuji Uni-blocker
Fuji Uni-blocker for selective lobar deflation
Device: Fuji Uni-blocker
Fuji Uni-blocker foe selective lobar deflation

Active Comparator: Cohen blocker
Cohen blocker for selective lobar deflation
Device: Cohen blocker
Cohen blocker for selective lobar deflation

Active Comparator: Arndt® blocker
Arndt® blocker for selective lobar deflation
Device: Arndt® blocker
Arndt® blocker for selective lobar deflation

Placebo Comparator: Endobronchial double lumen tube
Endobronchial double lumen tube for one lung ventilation
Device: Endobronchial double lumen tube
Endobronchial double lumen tube for one lug ventilation




Primary Outcome Measures :
  1. operative field conditions [ Time Frame: participants will be followed for the duration of surgery, an expected average of 3 hours ]
    The surgeons will be asked to rate the deflation of the target lung lobe using a 100-mm visual analog scale (VAS) (0: full inflated; 100: completely deflated).


Secondary Outcome Measures :
  1. time required to initially position the assigned device [ Time Frame: up to 8 minutes after position the assigned device ]
    the time between the passing of the double lumen tube or tracheal tube past the vocal cords and the confirmation by fiberoptic bronchoscope of the satisfactory position of the device

  2. number of intraoperative FOB examinations [ Time Frame: for 2 hours after start of surgery ]
    The number of intraoperative FOB examinations to assure proper position during surgery

  3. number of lung isolation device malpositionings [ Time Frame: for 2 hours after start of surgery ]
    The number of lung isolation device malpositionings after initial placement

  4. Arterial oxygenation [ Time Frame: 5 min after induction, 15 min after start of one lung ventilation, 30 min after start of one lung ventilation, 60 min after start of one lung ventilation ]
    Arterial oxygenation

  5. Heart rate [ Time Frame: 5 min after induction, 15 min after start of one lung ventilation, 30 min after start of one lung ventilation, 60 min after start of one lung ventilation ]
    Heart rate

  6. Blood pressure [ Time Frame: 5 min after induction, 15 min after start of one lung ventilation, 30 min after start of one lung ventilation, 60 min after start of one lung ventilation ]
    Blood pressure

  7. Cost [ Time Frame: for 1 hour after surgery ]
    Cost of the used devices



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical class of II to III
  • Elective thoracic surgery
  • no previous thoracic surgery on the operation
  • the lung lobe containing or adjacent to the lesion can be targeted for collapse

Exclusion Criteria:

  • emergency procedures
  • pneumonectomy
  • bilobectomy
  • history of infectious lesions
  • history of bleeding lung lesions
  • tracheotomy
  • Body mass index > 35 kg/m2
  • difficult airways

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032342


Locations
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Saudi Arabia
Dammam University
Khobar, Eastern, Saudi Arabia, 31952
Sponsors and Collaborators
Dammam University
Investigators
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Study Chair: Abdulmohsen Al Ghamdi, MD Associate Professor, of Anesthesia and Surgical ICU, University of Dammam, Al Khubar, Saudi Arabia
Study Chair: Mohammed Abdul Shafi, MD Assistant Professor of Anesthesia and Surgical ICU, University of Dammam, Al Khubar, Saudi Arabia.
Study Chair: Haytham Zien, MD Assistant Professor of Anesthesia and Surgical ICU, Dammam University
Study Chair: Alaa M Khidr, MD Assistant Professor Anaesthesiology and Surgical ICU, King Fahd Hospital of the University of Dammam, Al Khubar, Saudi Arabia
Study Chair: Yasser F El Ghoneimy, MD Associate Professor of Cardiothoracic Surgery, King Fahd Hospital of the University of Dammam, Al Khubar, Saudi Arabia.
Study Chair: Mohamed A Regal, MD Associate Professor of Cardiothoracic Surgery, King Fahd Hospital of the University of Dammam, Al Khubar, Saudi Arabia.

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Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT02032342     History of Changes
Other Study ID Numbers: Anesth-Nov13(1)
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018